Cranial Electrotherapy Stimulation in the Treatment of Depression and Anxiety: A Rare Path to Affordable Healthcare

Fisher Wallace Depression Treatment Stimulator

Wearable neurostimulation devices and digital health technologies are making mental health care better, cheaper and faster by enabling patients to treat themselves. Cranial electrotherapy stimulation (CES) is the most profound of these tools, because it possesses the broadest FDA regulatory scope of any medical device on the market: the treatment of depression, anxiety and insomnia. But what is CES? What are the risks, ie, the potential side effects? And what’s the evidence of its effectiveness?

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Many patients are familiar with the experience of seeing a psychiatrist who, over the course of a year, prescribes a series of different antidepressants to try and find what works. Each can come with side effects. And while drugs can appear to take the edge off depression and anxiety at first, the effect often does not last - typical of a placebo effect. Fortunately, there are medical devices that treat mood and sleep disorders without the side effects of drugs – albeit, they can cost $700.

How Cranial Electrotherapy Stimulation (“CES”) Devices Work?

There are two significant brands of CES devices: the Fisher Wallace Stimulator, which targets the US market, and a device produced by Electromedical Products International, which has a large international following. These devices work by delivering a low dose of electricity to the brain that has been shown in published studies to stimulate serotonin, melatonin and GABA production while lowering cortisol (the stress hormone) and modulating the brain’s default mode network.

Unlike SSRIs which inhibit neuronal receptors from absorbing serotonin, CES devices help the brain self-regulate neurochemical production. According to NIH research, SSRIs cause side effects in 38% of patients - in large part because it interferes with natural serotonin uptake. CES devices cause side effects in less than 1% of patients, and all the side effects are relatively minor: temporary headache or dizziness, or, very rarely, skin irritation at the electrode sites.

Patients use a CES device for 20 minutes, once or twice a day - while they read a book, watch TV or engage in some other quiet activity. That’s still a much bigger commitment to therapy than popping a pill once or twice a day, but a lot less to deal with in terms of side effects.

The first year will cost you between $600 - $700, and then about $50 a year after that (the cost of batteries and electrode sponges). An antidepressant prescription often costs $1200 over the course of a year - and that doesn’t include the doctor visits.

Evidence for CES Devices in Treating Depression and Anxiety

Clinical trials have been run with CES devices for decades, despite the devices already being on the market - a stark contrast to drug research which is almost always done before a drug comes to market, and not afterwards.

In 2014, a 115-subject, randomized double-blind, placebo-controlled study was published in the Journal of Affective Disorders that proved CES is effective for the treatment of anxiety and depression. None of the subjects who received active treatment experienced adverse events.

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In 2015, a pilot study conducted at Mount Sinai Beth Israel Hospital was published in the Journal of Nervous and Mental Disease that demonstrated CES effectiveness in treating bipolar II depression patients without causing side effects or hypomania. This pilot, strong enough to be published but not large enough to be definitive, is extremely good news to the six million bipolar patients in the United States, because SSRI medication has been proven to cause hypomania.

The following quote from the pilot study preface sums up why doctors and patients treating bipolar are so keen to find alternatives to medication: “Current pharmacological treatments for bipolar depression include the second-generation anti-psychotics, quetiapine and lurasidone, and a combination of olanzapine and the anti-depressant fluoxetine. Modestly effective, these drugs cause severe weight gain and metabolic syndrome. Other methods of treatment include anticonvulsant medications such as lamotrigine, valproic acid, and lithium, which are also marginally effective, though they have possible side effects of increased suicidal thoughts. Antidepressants in bipolar depression can only be used with extreme caution because of the significant risk of mania and cycle acceleration. Hence, finding an effective treatment for bipolar depression would greatly improve the lives of many who suffer from bipolar disorder.”

Today, doctors who consider these studies in combination with the clinical validity achieved by our device treating over 25,000 patients must engage in the following calculus: if there’s evidence of effectiveness and it doesn’t cause serious side effects, why shouldn’t I prescribe it?

References

1. Shealy CN, Cady RK, Wilkie RG, et al. Cerebral spinal fluid and plasma neurochemicals: response to cranial electrotherapy stimulation. J Neurol Orthop Med Surg 1998; 18:94-97

2. Feusner JD, Madsen S, Moody TD, Bohon C, Hembacher E, Bookheimer SY, Bystritsky A. Effects of cranial electrotherapy stimulation on resting state brain activity. Brain Behav. 2012 May;2(3):211-20. doi: 10.1002/brb3.45.

3. Elisa Cascade, Amir H. Kalali, MD, and Sidney H. Kennedy, MD, FRCPC
Real-World Data on SSRI Antidepressant Side Effects
Psychiatry (Edgmont). 2009 Feb; 6(2): 16–18.
Published online 2009 Feb.PMCID: PMC2719451

4. Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. Affect Disord. 2014 Aug;164:171-7. doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21.

5. Deimante McClure, BA, Samantha C. Greenman, BA, Siva Sundeep Koppolu, MBBS, Maria Varvara, MD, Zimri S. Yaseen, MD, and Igor I. Galynker, MD, PhD
A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression. J Nerv Ment Dis. 2015 Nov; 203(11): 827–835.
Published online 2015 Nov 12. doi: 10.1097/NMD.0000000000000378
PMCID: PMC4892785

6. Research Synthesis Report No. 21 | The Robert Wood Johnson Foundation | Mental disorders and medical comorbidity | February 2011.

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